Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01899742 | The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium | PHASE3 | COMPLETED | 497 | — | — | Sep 15, 2014 | Jul 22, 2015 | Jan 24, 2018 | 64 | United States, Argentina +8 |
| NCT02207829 | A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 1,017 | — | — | Sep 1, 2014 | Jun 15, 2015 | Jan 24, 2018 | 99 | United States, Argentina +11 |
| NCT01817764 | A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 707 | — | — | Mar 1, 2013 | Oct 25, 2013 | Nov 8, 2017 | 59 | United States, Argentina +5 |
| NCT01777334 | The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD | PHASE3 | COMPLETED | 905 | — | — | Jan 23, 2013 | Sep 24, 2013 | Jan 24, 2018 | 70 | United States, Argentina +7 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label \[OL\] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.
| Arm | Type | Description |
|---|---|---|
| Umeclidinium/Vilanterol | EXPERIMENTAL | Long-acting muscarinic antagonist (LAMA)/Long-acting Beta agonist (LABA) |
| Tiotropium | ACTIVE_COMPARATOR | Long-acting muscarinic antagonist (LAMA) |
| Umeclidinium 62.5 mcg + placebo | EXPERIMENTAL | Subjects will receive UMEC Inhalation Powder 62.5 mcg once daily via nDPI plus placebo once daily via HANDIHALER inhaler for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler |
| Tiotropium 18mcg + placebo | ACTIVE_COMPARATOR | Subjects will receive Tiotropium 18 mcg once daily via HANDIHALER inhaler plus placebo once daily via nDPI for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler |
| Umeclidinium/vilanterol Arm | EXPERIMENTAL | The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via the NDPI and placebo administered as one inhalation each morning and evening via ACCUHALER/DISKUS |
| Fluticasone propionate/salmeterol Arm | ACTIVE_COMPARATOR | The subjects will receive FSC 250/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS and placebo administered once-daily in the morning via NDPI |
| Name | Type | Description |
|---|---|---|
| Umeclidinium/Vilanterol 62.5/25 mcg | DRUG | Inhalation Powder |
| Tiotropium 18 mcg | DRUG | Inhalation Powder |
| Umeclidinium | DRUG | Umeclidinium 62.5 mcg once daily in the morning via nDPI |
| Umeclidinium matching placebo | DRUG | Umeclidinium matching placebo once daily in the morning via nDPI |
| Tiotropium | DRUG | Tiotropium 18 mcg once daily in the morning via HANDIHALER inhaler |
| Tiotropium matching placebo | DRUG | Tiotropium matching placebo once daily in the morning via HANDIHALER inhaler |
| Umeclidinium/vilanterol | DRUG | Dry white powder delivered via NDPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning |
| Fluticasone propionate/salmeterol | DRUG | Dry white powder delivered via ACCUHALER/DISKUS (1 strip with 60 blisters, containing 250 mcg fluticasone propionate and 50 mcg salmeterol per blister), administered as one inhalation of FSC 250/50 mcg each morning and evening |
| Placebo | DRUG | Placebo will be administered via ACCUHALER/DISKUS or NDPI. Dry white powder administered as one inhalation each morning and evening via ACCUHALER/DISKUS (1 strip with 60 blisters containing placebo) OR once-daily in the morning via NDPI (2 strips with 30 blisters each, containing placebo) |
Inclusion Criteria: * Type of subject: Outpatient. * Informed Consent: A signed and dated written informed consent prior to study participation. * Age: Subjects 40 years of age or older at Visit 1. * Gender: Male or female subjects. A female is eligible to enter and participate in the study if she ...